EU approves Boehringer's Pradaxa for stroke prevention in atrial fibrillation

There was good news for independent German drug major Boehringer Ingelheim yesterday, when the company gained European Union approval for its breakthrough oral anticoagulant, Pradaxa (dabigatran etexilate) for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke. This adds to the drug’s clearance last year in this indication in the all important US market (The Pharma Letter October 20, 2010), as well as in Canada, Japan, Australia and several other countries across four continents, the company noted.

This EU label extension means that, for the first time in over 50 years, millions of AF patients across Europe will have access to a new treatment for the prevention of AF-related strokes which is effective and convenient, and has demonstrated a good safety profile, the company said. In 2008 dabigatran etexilate was granted EU approval for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery.

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